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AAPS Sues the FDA to End Its Arbitrary Restrictions on Hydroxychloroquine

Sixth Circuit Affirms Dismissal of AAPS v. FDA

Without reaching the merits, on September 9, 2021, the Court affirmed the trial court’s dismissal of the AAPS case against FDA for withholding millions of doses of hydroxychloroquine donated to the National Strategic Stockpile, citing lack of standing (https://tinyurl.com/5dwmek7c). AAPS “failed to plausibly plead that any member has been injured by the actions of the Food and Drug Administration (FDA) that it criticizes,” the Court held. The Court ducked the issue of FDA’s intimidating statements that could have caused the preventable death of hundreds of thousands by denial of safe early COVID-19 treatment. “Much of the opinion is unjustified legal theorizing about the doctrine of legal standing, while lives are at stake,” states AAPS counsel Andrew Schlafly. “The Court did recognize that the FDA cannot interfere with off-label prescribing.”

June 21, 2021 Update: AAPS files letter with U.S. Court of Appeals for the Sixth Circuit – https://aapsonline.org/judicial/aaps-v-fda-hcq-06-21-2021.pdf

December 17, 2020 Update: AAPS files Reply Brief with U.S. Court of Appeals for the Sixth Circuit – https://aapsonline.org/judicial/aaps-v-fda-hcq-12-17-2020.pdf

October 28, 2020 Update: AAPS files Appeal Brief with U.S. Court of Appeals for the Sixth Circuit – https://aapsonline.org/judicial/aaps-v-fda-hcq-10-28-2020.pdf

September 1, 2020 Update: AAPS Reply in Support of Emergency Motion for Injunctive Relief – https://aapsonline.org/judicial/aaps-v-fda-hcq-9-1-2020.pdf

August 20, 2020 Update: AAPS files Emergency Motion for Injunctive Relief https://aapsonline.org/judicial/aaps-v-fda-hcq-8-20-2020.pdf

August 14, 2020 Update: AAPS files Notice of Appeal in the United States Court of Appeals for the Sixth Circuit from the final Judgment of the United States District Court for the Western District of Michigan – https://aapsonline.org/judicial/aaps-v-fda-hcq-notice-of-appeal-8-14-2020-.pdf

July 30, 2020 Update: AAPS files Motion to Expedite – https://aapsonline.org/judicial/aaps-v-fda-hcq-7-30-2020.pdf

July 20, 2020 Update: https://aapsonline.org/more-evidence-presented-for-why-hydroxychloroquine-should-be-made-available-in-a-new-court-filing-by-aaps/

June 22, 2020 Update: https://aapsonline.org/preliminary-injunction-sought-to-release-hydroxychloroquine-to-the-public/

PDF of complaint: http://aapsonline.org/judicial/aaps-v-fda-hcq-6-2-2020.pdf

Today, June 2, 2020, the Association of American Physicians & Surgeons (AAPS) filed a lawsuit, AAPS v. FDA, against the Food and Drug Administration to end its arbitrary interference with the use of hydroxychloroquine (HCQ), which President Trump and other world leaders have taken as a prophylaxis against COVID-19.

Two million doses of HCQ are being sent by the Trump Administration to Brazil to help medical workers there safeguard themselves against the spread of the virus. But at the same time the FDA continues to block Americans’ access to this medication.

HCQ has been approved as safe by the FDA for 65 years, and the CDC states on its website that “CDC has no limits on the use of hydroxychloroquine for the prevention of malaria.”

More than 150 million doses have been donated to the strategic national stockpile controlled by the federal government, but unjustified FDA restrictions limit its use to only hospitalized patients for whom a clinical study is unavailable. Hospitals are even returning HCQ to the stockpile because they are not able to use it effectively.

“It is shocking that medical workers in Brazil will have access to HCQ as a prophylaxis while Americans are blocked by the FDA from accessing the same medication for the same use,” observes AAPS Executive Director Jane Orient, M.D.

“There is no legal or factual basis for the FDA to limit use of HCQ,” states AAPS General Counsel Andrew Schlafly. “The FDA’s restrictions on HCQ for Americans are completely indefensible in court.”

Many foreign nations, including China, India, South Korea, Costa Rica, United Arab Emirates, and Turkey, use HCQ for early treatment and prevention of COVID-19,  AAPS points out.

“Entrenched, politically biased officials at the FDA should not be allowed to interfere with Americans’ right to access medication donated to the federal government for public use,” Schlafly says. “By preventing Americans’ use of HCQ as a prophylaxis, the FDA is infringing on First Amendment rights to attend religious services or participate in political events such as political conventions, town halls, and rallies in an important election year.”

“FDA Commissioner Stephen Hahn states that the FDA does not interfere with physicians’ ability to prescribe HCQ, and yet at the same time the FDA denies access by millions of Americans to 150 million doses of it in the national stockpile,” Schlafly adds. “This irrational hoarding by government is an abuse of power.”

The Association of American Physicians and Surgeons (AAPS) has represented physicians of all specialties in all states since 1943. The AAPS motto is omnia pro aegroto, meaning everything for the patient.

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